Glecaprevir and Pibrentasvir for Hepatitis C
Phase-Based Progress Estimates
Effectiveness
Safety
Hepatitis C+7 More
Glecaprevir and Pibrentasvir - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial studied the effects of pan-genotypic DAA therapy given to kidney transplant recipients to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney.
Eligible Conditions
- Hepatitis C
- Chronic Kidney Disease (CKD)
- Kidney Failure
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 1 Year Study Period
1 Year Study Period
Adverse Events
Allograft Function
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation
Week 16
SVR12
Week 2
HCV RNA Viral Load
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Treatment with Direct Acting Antiviral for HCV
1 of 1
Experimental Treatment
80 Total Participants · 1 Treatment Group
Primary Treatment: Glecaprevir and Pibrentasvir · No Placebo Group · Phase 4
Treatment with Direct Acting Antiviral for HCV
Drug
Experimental Group · 1 Intervention: Glecaprevir and Pibrentasvir · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pibrentasvir
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year study period
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,673 Previous Clinical Trials
30,828,576 Total Patients Enrolled
14 Trials studying Hepatitis C
1,069 Patients Enrolled for Hepatitis C
Nahel Elias, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
University Of Damascus (Medical School)
North Oakland Medical Center (Residency)
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:No clinically significant liver disease was found at the time the clinical team determined the patient was ready for a transplant.
The person is eligible for a kidney transplant if they meet the criteria of the Met MGH Transplant Center and are already listed for a kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy).
during the study and for six weeks after the last dose of study drug
Women who take part in this study must agree to use birth control in a way that minimizes their risk of exposure to mycophenolate
The donor is deceased
result
The following is a detectable HCV NAT test result
KDPI score is less than or equal to 0.
The donor has met the traditional selection criteria, which are acceptable for transplantation per usual evaluation.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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